July's top stories: Immunocore, Genentech to develop ImmTACs
Immunocore and Genentech have formed a strategic alliance to develop ImmTACs against multiple cancers, while ARTES Biotechnology and Bio Farma have collaborated to develop and manufacture vaccine candidates. Drugdevelopment-technology.com wraps up key headlines from July 2013.
Biotechnology company Immunocore has signed a strategic alliance with Genentech, a member of the Roche Group, to develop novel biological drugs known as ImmTACs against multiple cancers.
The research collaboration and licensing agreement will make use of Immunocore's ImmTAC technology for the discovery and development of multiple novel cancer targets.
Immunocore chief executive officer James Noble said: "We are very pleased to have Genentech, a recognised leader in oncology, on board as our first major partner to discover, develop and commercialise ImmTAC therapies against multiple cancer targets."
CSL Behring has reported results from a pharmacokinetic study of novel investigational recombinant coagulation single-chain factor VIII (rVIII-SingleChain), which demonstrated advantages over multichain rFVIII for the treatment of haemophilia A.
The study, part of the AFFINITY clinical trial programme, demonstrated an improved half-life of rVIII-SingleChain against the comparator, octocog alfa, in addition to a safety and efficacy profile that supports progress to late-stage clinical development.
The Medical University of Vienna, Austria, professor Dr Ingrid Pabinger-Fasching said the data suggests that the recombinant single-chain design for Factor VIII may help address the need for haemophilia A treatment with a longer half-life.
"A treatment with an improved half-life has the potential to increase the quality of life for those with severe hemophilia A by reducing the number of factor VIII protein infusions required to restore normal blood clotting," Pabinger-Fasching added.
DBV Technologies, a developer of treatments for food allergies, has completed enrolment of peanut-allergic subjects for phase IIb of a clinical trial with Viaskin Peanut.
Viaskin Peanut, developed for peanut allergies, was granted fast track designation by the US Food and Drug Administration in February 2012.
The trial, known as Viaskin Peanut's efficacy and safety (Vipes), began in August 2012, when around 315 and 221 participants began being screened and randomised in Europe and North America respectively.
The European Commission has approved Novartis's Lucentis (ranibizumab) for the treatment of visual impairment due to choroidal neovascularisation (CNV) secondary to pathologic myopia (myopic CNV).
First launched in 2006 and developed by Genentech and Novartis, the ophthalmology drug Lucentis is a humanised therapeutic antibody fragment that restricts biologically-active forms of vascular endothelial cell growth factor-A (VEGF-A).
The latest approval is the fourth for the drug in the EU, where it is already licensed to treat wet age-related macular degeneration (AMD), visual impairment due to diabetic macular edema and for visual impairment due to macular edema secondary to retinal vein occlusion.
ARTES Biotechnology and Bio Farma have collaborated to develop and manufacture vaccine candidates.
As part of the mutually agreed collaboration, both companies have already signed a first agreement for virus-like particles (VLP) based vaccine technology transfer in Bandung, Indonesia.
ARTES's Metavax patent protected VLP technology has been designed to develop and produce safe and cost-effective vaccines, claimed the company.
When compared to other existing VLP approaches in the market, the Metavax platform provides a highly potent immune response and enhanced protection as it is based on modifications to duck the hepatitis B virus.
Takeda Pharmaceutical Company has unblinded the ELM-PC 5 Phase III study of non-steroidal, selective inhibitor of 17,20-lyase, Orteronel, in patients with metastatic, castration-resistant prostate cancer (mCRPC) that has progressed post-chemotherapy based on interim analysis.
Pre-specified interim analysis, which was conducted by the Independent Data Monitoring Committee (IDMC), indicated the study would not meet the primary endpoint of improved overall survival.
Designed to assess orteronel plus prednisone compared with placebo plus prednisone, the study's interim analysis failed to show an advantage for orteronel plus prednisone for the secondary endpoint, radiographic progression-free survival (rPFS) over the control arm.
Celgene has decided to terminate the Phase III ORIGIN trial of Revlimid (lenalidomide) due to imbalance in the number of deaths in lenalidomide patient-group compared to patients treated with chlorambucil.
The open-label, ORIGIN study was put on hold by the US FDA on 12 July and asked to discontinue lenalidomide treatment.
The action will be officially communicated to all clinical investigators, who are conducting the ongoing chronic lymphocytic leukaemia studies using the agent.
Though no specific causality for the imbalance has been identified to date, 34 deaths out of 210 patients in the lenalidomide arm versus 18 deaths out of 211 patients in the chlorambucil arm have occurred.
A*STAR's Genome Institute of Singapore (GIS) scientists have discovered potential drug targets for triple-negative breast cancer (TNBC) using integrated genomic approaches.
The GIS scientists, in partnership with other research institutions, found that UBASH3B is a protein tyrosine phosphatase that plays a key role in the invasive growth of TNBC.
According to their findings, UBASH3B is overexpressed in one third of TNBC patients and is responsible for regulating the activity of a key breast cancer gene.
"Being able to predict which patients are more likely to relapse is important since these patients may benefit from more aggressive treatments."
After conducting further studies in a mouse model, the researchers concluded the growth of TNBC cell and lung metastasis can be reduced by deleting the gene expression.